Senior Manager, Quality Assurance

About Acadia Pharmaceuticals

Acadia Pharmaceuticals is committed to turning scientific promise into meaningful innovation that makes a real difference for underserved neurological and rare disease communities around the world. Our commercial portfolio includes the first and only FDA-approved treatments for Parkinson's disease psychosis and Rett syndrome. We are actively developing the next wave of therapeutic advancements through a robust and diverse pipeline that includes mid- to late-stage programs in Alzheimer's disease psychosis and Lewy body dementia psychosis, along with earlier-stage programs addressing additional unmet patient needs. At Acadia, we're here to be their difference.

About the Role

On behalf of Acadia GmbH, the Senior Manager, Quality Assurance Operations will serve as a key quality leader responsible for overseeing cGMP European operations within Acadia Pharmaceuticals' global Quality Assurance department. This role encompasses broad oversight of cGMP activities conducted at Contract Manufacturing Organizations (CMOs), quality release of API and drug product, raw materials, and intermediates intended for commercial and clinical use, and ensuring alignment with Swissmedic, EMA, MHRA, and other applicable international regulatory standards.

This is a highly cross-functional role that interfaces with CMO partners, internal product development teams, and global QA leadership. The position reports directly to the Director, Quality Assurance, Acadia GmbH, and operates in a hybrid work model.

Responsibilities

• Oversee assigned CMOs from a quality perspective, including review and approval of CMO quality documentation and ensuring conformance to established quality agreements
• Manage the Acadia batch disposition process for API, drug product, raw materials, and intermediates
• Participate in the design, implementation, and ongoing management of the Acadia GMP quality management system in accordance with Swissmedic, EMA, MHRA, and other applicable international regulations
• Serve as a key point of contact with CMO partners, ensuring integrated and coordinated activities related to cGMP production and continuous improvement initiatives
• Manage and/or provide oversight to QA personnel involved in CMO technology transfer, process validation, batch documentation, registration batch review, and process changes and deviations
• Manage internal investigations and change management activities, establishing effective CAPA plans and providing oversight of CMO investigation and change management activities
• Lead and participate in GMP supplier audits and internal audits, as well as Acadia's documentation control systems as needed
• Participate in and lead continuous improvement of Acadia quality management systems in alignment with GMP standards and current industry best practices
• Ensure adequate QA representation on all GMP product development teams and provide direction to QA representatives on those teams
• Participate in Quality Operations functions including Material Review Board, quality board, and strategic planning efforts as required
• Contribute to formal risk assessment activities and develop metrics to support product and process review efforts
• Support annual product reviews, product quality reviews, and continuous process verifications (CPV)
• Develop department goals and objectives for senior management review in alignment with Acadia's strategic planning priorities
• Recommend changes to policies and establish procedures affecting the functional area, including those with potential company-wide impact
• Perform additional duties as assigned

Requirements

• Education: Pharm D, Master's, or Bachelor's degree in Chemistry, Biology, Pharmacy, or a related life science discipline is required
• A minimum of 5 years of related and progressively responsible experience within the pharmaceutical or biopharmaceutical industry
• Demonstrated knowledge of Quality Assurance activities and ICH guidelines, as well as Swissmedic, EMA, MHRA, and other international GMP regulations as they relate to clinical trials, product development, commercial manufacturing, and technology transfer
• Demonstrated proficiency in interpreting and applying cGMP regulations across Swissmedic, EMA, MHRA, and other international regulatory frameworks
• Experience implementing and managing quality management systems is a strong advantage
• Experience conducting internal and supplier audits and manufacturing facility inspections is a strong advantage
• Strong ability to interpret and apply quality standards for implementation and review purposes
• Excellent flexibility, multitasking capability, attention to detail, organizational skills, and sound professional judgment with the ability to prioritize effectively
• Skilled communicator with the ability to clearly present department or area issues, results, and technical information across functional areas and to diverse stakeholders
• Demonstrated ability to build cooperative relationships, lead cross-functional team efforts, and organize resources to achieve